GUEST COLUMNISTS

• Oral Solid Dosage Formulation And Process Development: A Case Study

  This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.

• The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations

  The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

• AstraZeneca's Digitally Connected Strategy For API Manufacturing

  The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

• 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?

  The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

• USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli

  Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.

• Are We Witnessing A New "Age Of The CDMO"?

  Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.

• The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond

  These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

• RNase Control: An Overview With Market Trends

  This article shares an overview of ribonuclease (RNase) control and some associated macro market research.